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Press release submission | Nov 9, 2019

TRIO HEALTH: Releases Findings from Real-World Studies in Hepatitis C and B Patients

Trio Health issued the following announcement on Nov. 8.

Trio Health, a leading provider of real-world evidence, today announced results from four studies presented at the Liver Meeting of the American Association for the Study of Liver Diseases.

Founded in 2013, Trio tracks a patient through the entire treatment journey by combining disparate information from the physician, pharmacy, and payer 'trio,' to produce comprehensive and high-quality databases that are on caliber with FDA-level rigor.

"These studies highlight Trio Health's continued commitment to understand care of real-world patients with viral hepatitis,'' said Scott Milligan, PhD, Head of Analytics, Trio Health. "Since our initial HCV studies in 2013, we've observed repeating themes across diseases where new, more efficacious, and safer therapies have been approved; namely, challenges in access to these therapies, understanding potential effects of long-term treatment with newer therapies, and potential concerns with the use of these therapies in diseases with changing population demographics."

FRI-0486 - DIFFERENTIAL TENOFOVIR ALAFENAMIDE (TAF) ADOPTION IN HBV-INFECTED POPULATIONS; ASSESSMENT OF CARE IN US CLINICAL PRACTICE - Lead Author: Michael Curry, MD

Previously, Trio Health reported increased HBV suppression, ALT normalization, and improved renal function in patients who were treated with tenofovir alafenamide (TAF), the most recently approved drug for HBV. However, certain patients that would potentially benefit from switching to TAF, those with osteopenia/osteoporosis, suboptimal eGFR, elevated ALT, or advanced liver fibrosis, remained on non-TAF therapies at the time of that study. In this follow up study of 1037 patients, TAF adoption in the 2 years since approval was <50% in patients with osteopenia/osteoporosis, suboptimal eGFR, elevated ALT, or advanced liver fibrosis. Notably, adoption was similar in patients without these disease features, suggesting that the presence of these risk factors was insufficient for access.

FRI-0487 - LONGER-TERM EXPERIENCE WITH TENOFOVIR ALAFENAMIDE (TAF) IN HBV-INFECTED PATIENTS; CHANGES IN EGFR, FIB4, ALT, AND DNA SUPPRESSION - Lead author: K. Rajender Reddy, MD

This study evaluated virologic suppression rates, eGFR, fibrosis, and ALT in 270 patients on longer term (48+ weeks) TAF therapy for Hepatitis B in U.S. clinical practice. Statistically significant improvements occurred in HBV DNA suppression and mean ALT. In this population, changes in mean eGFR and fibrosis severity did not reach significance at 48+ weeks compared to baseline. However, 22% of patients with renal impairment (eGFR <60 ml/min) improved to eGFR >60 ml/min at 48+ weeks and 19% of patients with moderate to severe fibrosis at baseline improved to low to moderate fibrosis at 48+ weeks.

SUN-1500 - PANGENOTYPIC THERAPIES GLECAPREVIR-PIBRENTASVIR (GLE-PIB) AND SOFOSBUVIR-VELPATASVIR-VOXILAPREVIR (SOF-VEL-VOX) AFTER FAILURE WITH INTERFERON (IFN)-FREE DIRECT-ACTING ANTIVIRAL (DAA) TREATMENT FOR HEPATITIS C - Lead author: Steven L Flamm, MD

Despite the remarkable effectiveness of IFN-free DAA treatment in real-world HCV care, treatment failures remain a challenge in disease eradication. In this study, HCV-infected patients with prior DAA failure/relapse achieved significantly higher intent to treat (ITT) and per protocol (PP) SVR rates with SOF-VEL-VOX compared to GLE-PIB both before and after adjustment for clinical differences.

SUN-1503 - DRUG-DRUG INTERACTIONS (DDIs) WITH PANGENOTYPIC DIRECT-ACTING ANTIVIRALS (DAAs) IN PATIENTS WITH HEPATITIS C; UNDERSTANDING THE POPULATIONS AT RISK AND REAL-WORLD CARE MANAGEMENT - Lead author: Michael Curry, MD

Drug-drug interactions are a concern in the aging US population and while estimates of possible interactions have been reported, the actual management of such in patients with HCV is uncertain. Using two different data sources, this study reported real-world frequencies of DDIs with pangenotypic DAAs and actions taken, manifested by pharmacist recommendations and care implemented by the provider. Potential DDIs (weak, possible, contraindicated) were identified in 41% GLE-PIB prescribed patients, 27% SOF-VEL, and 53% SOF-VEL-VOX. However, pharmacist recommendations were largely limited to contraindicated DDIs and observed for 12% GLE-PIB prescribed patients, 7% SOF-VEL, and 13% SOF-VEL-VOX. Pharmacist recommendations were not followed for 15% of patients. Though prevalence of DDI is very common for HCV treatment and more frequent in protease-containing regimens, pharmacist recommendations in the real-world are largely limited to contraindicated treatment and physician response to recommendations vary.

About Trio Health

Trio Health's mission is to improve the quality of care in patient outcomes through coordinating the efforts of all patient care stakeholders. Their first-of-its-kind Multi-Disease Platform (MDX) tracks patients throughout the course of their treatment, giving pharmaceutical/biotechnology companies, specialty pharmacies and physicians access to information and opportunities that simply doesn't exist anywhere else. Learn more at www.triohealth.com.

Original source can be found here.

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